The newly cleared MRIdian Linac device replaces the cobalt it utilized with linear accelerator technology, Cleveland-based ViewRay said.
“We are excited to have CE Mark approval and to begin selling MRIdian Linac within Europe. We believe the radiation oncology community has been eagerly awaiting the availability of a clinical MRI-guided Linac system, and we’re pleased to bring them ViewRay’s well-established MRI-guidance capabilities with the familiar functionality of a linac-based platform. We now look forward to progress on our 510(k) filing with the FDA,” CEO Chris Raanes said in prepared remarks.
ViewRay said it’s already submitted a 510(k) application to the FDA seeking approval for the MRIdian Linac device.
Earlier this month, the company said it won clearance from the China Food & Drug Administration for the MRIdian system, which is designed to integrate full-time MR imaging, cobalt radiation delivery and software automation for cancer treatment throughout the body, the company said.